October 2023 Regulatory Update

Medical Device made Easy Podcast · Oct 4, 2023

EU

Manual on Borderline and classification for Medical Devices Update – New entries to the file: https://health.ec.europa.eu/system/files/2023-09/md_borderline_manual_en.pdf

Q&A on Annex XVI Products – Check transition timeline: https://health.ec.europa.eu/system/files/2023-09/md_new-reg_annex-xvi_q-n-a_transition-prov.pdf

Italy: Custom-made medical device registration – Specific website available: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6352

Ireland: Custom-made device Webinar October 19th, 2023 – Webinar to…